Unsurpassed experience
After seven years of implantation worldwide, Zenith Fenestrated has become the EVAR market leader for treating patients who have an infrarenal neck as short as 4 mm.

Patient-specific fenestrations and scallops
Zenith Fenestrated features fenestrations and scallops that accommodate a patient’s unique anatomy, and it is compatible with a selection of Zenith components such as the Zenith Spiral-Z™ AAA Iliac Leg Graft.

Patient-specific modularity
Its patient-specific modularity means that Zenith Fenestrated allows you to offer the less-invasive EVAR option to even more of your patients.

Intended Use

The Zenith Fenestrated AAA Endovascular Graft with the H&L-B One-Shot Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair, including:

Zenith Fenestrated MR Marking Statement

Non-clinical testing has demonstrated that the Zenith Fenestrated AAA Endovascular Graft is MR Conditional. A patient with this endovascular graft in place for at least 6 months can be scanned safely under the following conditions:

Static magnetic field of 3.0 Tesla or 1.5 Tesla

Maximum spatial magnetic gradient of 720 Gauss/cm or less

Maximum MR system reported, whole-body-averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of scanning or less (i.e., per scanning sequence)

Normal operating mode.

Static Magnetic Field
The static magnetic field for comparison to the above limits is the stactic magnetic field pertinient to the patient (i.e., outside of scanner covering, accessible to a patient or individual).

The image artifact extends throughout the anatomical region containing the device, obscuring the view of immediately adjacent anatomical structures within approximately 20 cm of the device, as well as the entire device and its lumen, when scanned in nonclinical testing using the sequence: Fast spin echo, in a 3.0 Tesla, Excite, GE Electric Healthcare, with G3.0-052B Software, MR system with body radiofrequency coil.

For all scanners, the image artifact dissipates as the distance from the device to the area of interest increases. MR scans of the head and neck and lower extremities may be obtained without image artifact. Image artifact may be present in scans of the abdominal region and upper extremities, depending on distance from the device to the area of interest.

Cook recommends that the patient register the MR conditions disclosed in this IFU with the MedicAlert Foundation. The MedicAlert Foundation can be contacted in the following manners: